Toviaz

(Fesoterodine)

ApprovedSmall molecule

Toviaz is a small molecule that works as a Muscarinic Acetylcholine Receptor M2 Antagonist; Muscarinic Acetylcholine Receptor M3 Antagonist.[2] It is being used across 8 indications, with its most advanced program in Approved.[1]

Toviaz is one of 149 small molecule programs targeting Neurogenic bladder. It is currently in Approved.

Indications

Total Trials

Active Trials

148

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Neurogenic BladderApproved

Autonomic DysreflexiaActive, not recruiting

Cognitive ImpairmentActive, not recruiting

StrokeActive, not recruiting

Stress Urinary IncontinenceActive, not recruiting

PolyuriaActive, not recruiting

Urinary IncontinenceActive, not recruiting

Overactive BladderApproved

Neurogenic BladderApproved

Approved

Autonomic DysreflexiaPhase 2

Active, not recruiting

Cognitive ImpairmentPhase 2

Active, not recruiting

StrokePhase 1

Active, not recruiting

Stress Urinary IncontinencePhase 2

Active, not recruiting

PolyuriaApproved

Active, not recruiting

Urinary IncontinenceApproved

Active, not recruiting

Overactive BladderApproved

Approved

Competition

Competitive Landscape

461 competitors in Stroke

#DrugCompanyPhaseTrials

Toviaz

Pfizer

Approved

1 2

Zometa

Pfizer

Preclinical

1 3

Folvite

Eli Lilly

Preclinical

1 4

Repatha

Pradaxa

3 6

Botox

RRevance Therapeutics, Inc.

Preclinical

2 7

Alka-Seltzer

AAbbott

Preclinical

1 8

Haldol

DDePuy Orthopaedics

Preclinical

1 9

Inderal

Mylan Pharmaceuticals Inc

Botulinum Toxin a

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Overactive Bladder16 trials

Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder

Completed·LLG Life Sciences·Phase 4·NCT01578304·207 enrolled

Fesoterodine "add-on" Male Overactive Bladder Study

Completed· Pfizer logo

Pfizer·Phase 3·NCT00546637·947 enrolled

Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children

Completed·SStéphane Bolduc·Phase 3·NCT02327936·62 enrolled

Show 13 more trials

Comparative Urine Proteomic Studies of Overactive Bladder in Humans

Completed·WWashington University School of Medicine·N/A·NCT01367886·21 enrolled

Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

Completed· Pfizer logo

Pfizer··NCT00691093·823 enrolled

This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder

Completed· Pfizer logo

Pfizer··NCT00943735·774 enrolled

Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years

Completed· Pfizer logo

Pfizer·Phase 2·NCT00857896·21 enrolled

Extension Study of Fesoterodine for Overactive Bladder Syndrome in Children.

Completed·SStéphane Bolduc·Phase 3·NCT02614482·26 enrolled

Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

Completed· Pfizer logo

Pfizer·Phase 3·NCT00611026·2,417 enrolled

Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania

Completed· Astellas logo

Astellas··NCT03602508·5,589 enrolled

A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

Completed· Pfizer logo

Pfizer·Phase 4·NCT00911937·963 enrolled

A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

Completed· Pfizer logo

Pfizer·Phase 4·NCT00928070·566 enrolled

A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China

Completed· Astellas logo

Astellas··NCT03572231·805 enrolled

A Study of Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Lap. Prostatectomy

Completed·—·Phase 4·NCT01661166·3 enrolled

Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder

Completed· Pfizer logo

Pfizer·Phase 4·NCT01054222·31 enrolled

A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.

Completed· Pfizer logo

Pfizer·Phase 4·NCT01302054·990 enrolled

Single Dose2 trials

Phase1, Single Dose, Crossover Study to Determine Bioequivalence

Completed· Pfizer logo

Pfizer·Phase 1·NCT00786240·37 enrolled

Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect

Completed· Pfizer logo

Pfizer·Phase 1·NCT00807118·108 enrolled

Tics1 trial

The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00911235·28 enrolled

Stress urinary incontinence1 trial

Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients

Completed· Pfizer logo

Pfizer·Phase 2·NCT01042236·22 enrolled

Trial1 trial

Solifenacin Succinate Versus Fesoterodine A Comparison Trial for Urgency Symptoms

Unknown status·RRambam Health Care Campus·N/A·NCT01595152·60 enrolled

13 more indications

Treatment1 trial

Bringing Simple Urge Incontinence Diagnosis & Treatment to Providers (BRIDGES)

Completed·UUniversity of California, San Francisco·Phase 4·NCT00862745·645 enrolled

Parkinson's Disease1 trial

Fesoterodine on Urgency Episodes in Parkinson's Disease Population

Terminated·SSir Mortimer B. Davis - Jewish General Hospital·Phase 4·NCT02385500·5 enrolled

Lip1 trial

Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder

Completed· Pfizer logo

Pfizer··NCT01260311·508 enrolled

Autonomic Dysreflexia1 trial

Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)

Completed·UUniversity of British Columbia·Phase 2·NCT02676154·15 enrolled

Prevention1 trial

Fall Prevention in Older Adults With OAB

Completed·UUniversity of Pennsylvania·Phase 4·NCT03946124·74 enrolled

Desmopressin1 trial

Comparison Between Desmopressin and Fesoterodine for Treatment of Night Time Voiding in Women Aged 65 and Older

Terminated·MMount Sinai Hospital, Canada·Phase 2/3·NCT02262936·4 enrolled

Adult1 trial

UK Study Assessing Flexible Dose Fesoterodine in Adults

Completed· Pfizer logo

Pfizer·Phase 4·NCT00806494·331 enrolled

Drug1 trial

Drug Use Investigation for Toviaz

Completed· Pfizer logo

Pfizer··NCT01936870·2,521 enrolled

Elderly1 trial

A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01161472·20 enrolled

Effectiveness1 trial

A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

Completed· Pfizer logo

Pfizer·Phase 4·NCT01302067·2,012 enrolled

Stroke1 trial

Neuropathic Investigation and Anticholinergic Treatment of Bladder Dysfunction in Diabetes and Stroke Patients

Withdrawn·SSaint Thomas Health·Phase 1·NCT00713921

Cognitive impairment1 trial

A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment

Completed·UUniversity of Alberta·Phase 2·NCT02240459·47 enrolled

Unspecified4 trials

A Bioequivalence Study Of 4 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00902187·36 enrolled

This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

Completed· Pfizer logo

Pfizer·Phase 1·NCT01286454·20 enrolled

Fesoterodine Flexible Dose Study

Completed· Pfizer logo

Pfizer·Phase 3·NCT00536484·896 enrolled

Show 1 more trial

A Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT00902681·36 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 31, 2008

TOVIAZ

NDA NDA022030

Sources

References

[1]
ClinicalTrials.gov — 37 trial records for Fesoterodine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fesoterodine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fesoterodine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022030). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Toviaz. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Muscarinic Acetylcholine Receptor M2 Antagonist; Muscarinic Acetylcholine Receptor M3 Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Pfizer

Patent Landscape[5]

Patent Cliff

Jun 7, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8088398Jun 7, 2027

7807715Jun 7, 2027

8501723Jun 7, 2027

7807715*PEDDec 7, 2027

8088398*PEDDec 7, 2027

1 more patents

8501723*PEDDec 7, 2027

Toviaz

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Overactive Bladder16 trials

Single Dose2 trials

Tics1 trial

Stress urinary incontinence1 trial

Trial1 trial

Treatment1 trial

Parkinson's Disease1 trial

Lip1 trial

Autonomic Dysreflexia1 trial

Prevention1 trial

Desmopressin1 trial

Adult1 trial

Drug1 trial

Elderly1 trial

Effectiveness1 trial

Stroke1 trial

Cognitive impairment1 trial

Unspecified4 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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